Kornimate/medical-research-clean huggingface dataset:
the effect of muscular endurance on disability level and participation in life

Conditions: Neck Pain

Summary: non-specific neck pain (nsba), which is one of the most common causes of neck pain in the literature, occurs as a result of a postural or mechanical cause without a specific pathology or injury to the musculoskeletal system. nsba causes an increase in superficial cervical muscle activity, and a decrease in deep cervical muscle activity, which contains a large amount of muscle spindles. patients with chronic neck pain face functional limitations in many ways. evaluation of disability as a result of loss of functions related to neck pain is necessary to cope with neck pain. in the icf activity and participation section due to neck pain, it is stated that the daily life activities of the person are limited due to neck pain, both at work and at home, and with this, the level of disability of the person increases. loss of endurance, on the other hand, appears as a physical marker in the development of chronic neck pain due to the effect of muscle functions in patients who have problems in the neck region, according to icf.

patients with non-specific neck pain who volunteered to participate in the study and who met the inclusion criteria of the study will be included in the study after signing the voluntary consent form. first of all, the demographic and clinical characteristics of the patients will be questioned with the evaluation form. the personal information of the patients (gender, height, weight, smoking, etc.) and clinical status (pain type, pain intensity, muscle endurance measurements) will be recorded by the physiotherapist in the evaluation form. in addition to the evaluation form, the northwick park neck pain questionnaire will evaluate the patients' neck disability, while the keele participation evaluation will evaluate their level of participation in life.

Eligibility criteria:
inclusion criteria: * voluntary consent to participate in the study * clinical diagnosis of non spesific neck pain exclusion criteria: * there is physical/mental problem that may prevent exercise

Keywords: non specific neck pain endurance disability participation pain
improved characterisation of eclampsia

Conditions: Eclampsia Preeclampsia

Summary: eclampsia is a serious pregnancy complication.in our study we aim to characterize the clinical signs and symptoms that occur prior to the onset of eclampsia in a prospectively collected cohort.and compare these characteristics to women with preeclampsia and healthy normal pregnancies to identify which features represent a unique clinical signature for eclampsia to form a simple predictive algorithm .

eclampsia is a serious pregnancy complication that occurs when a pregnant woman - or new mother - experiences seizures associated with hypertension. these seizures pose a major risk to the life and the health of mothers and unborn babies. signs or symptoms of severe preeclampsia are not always present or easy to recognise before a woman develops eclampsia. this is why it can be difficult to tell which women are likely to develop eclampsia before the first seizure occurs. if we can identify the features that are most common and unique to eclampsia, these could be used to develop a tool to help identify the women displaying signs or symptoms that occur prior to the onset of eclamptic seizures. this would mean that treatment to prevent seizures could be targeted to the right women and quickly administered before they become extremely unwell with this life-threatening complication. rates of eclampsia are far greater in low to middle income countries , with an estimated 16-69 cases of eclampsia per 10,000 livebirths. thus, research conducted in lmic settings allow for the prospective recruitment of a relatively large cohort of women with eclampsia. they are a useful target population to prospectively characterise the signs and symptoms preceding the disease. such characterisation may yield a unique clinical signature for eclampsia and the development of a predictive algorithm.

Eligibility criteria:
inclusion criteria: 1. eclampsia: * diagnosed as new onset generalized tonic colonic seizures or coma in pregnant women or women who have recently given birth. * singleton pregnancies. * all gestational ages, including post-partum eclampsia * enrolment to the study must occur within 7 days of an eclamptic episode women must be coherent and able to provide informed consent prior to enrolment 2. preeclampsia: ● diagnosed as new onset of hypertension (\>140 mmhg systolic or \> 90 mmhg diastolic) after the 20th week of gestation and the coexistence of one or more of the following new onset conditions:proteinuria ,other maternal organ evolvement. * singleton pregnancy. * have not experience an eclamptic episode 3. normotensive controls: * healthy normotensive pregnant woman recruited from women seeking maternity services during the same or similar period * matched 1:1 for each eclampsia and preeclampsia case * matched by closest gestational age at recruitment to cases and parity exclusion criteria: * women with multiple pregnancies. * women with seizures attributed to a diagnosis other than eclampsia such as; central nervous system infections, a history of seizures or epilepsy, medications and/or illicit drug use. * women unable to provide informed consent
prospective validation of circulating tumor cells & circulating endothelial cells as biomarkers in renal cancer

Conditions: Clear Cell Renal Cancer; Circulating Tumor Cells; Circulating Endothelial Cells; Prognostic Biomarkers; Predictive Biomarkers

Summary: circulating tumor cells (ctcs) have prognostic value in several tumor types, and increasing evidence suggests that molecular characterization of ctcs can serve as a "liquid biopsy" to understand and address treatment resistance. the goal of this proposal is to demonstrate that ctcs can be accurately enumerated and characterized in metastatic clear cell renal cancer (ccrc) and can serve as prognostic/predictive biomarkers to improve treatment. the challenge surrounding ctc analysis in ccrc is that most ctc technologies (including the clinical gold-standard cellsearch®) depend in epithelial markers such as epcam that are expressed at low or heterogeneous levels in ccrc. members of the research team have developed a novel ctc microfluidic technology that can effectively detect ctcs that are completely undetectable by cellsearch® because of very low epcam expression, as well as allowing for ctc recovery for downstream molecular characterization. the goal of this proposal is therefore to test the hypotheses that (1) the microfluidics ctc technology will have better sensitivity/specificity relative to the cellsearch in metastatic ccrc; and (2) enumeration of ctcs in metastatic ccrc patients (n=66) will have prognostic value, while molecular characterization of ctcs for expression of biomarkers (vhl, vegf, mtor, hif1/hif2, akt) related to ccrc etiology will be predictive of response/resistance to targeted therapies. although ccrc is relatively uncommon, the lack of established adjuvant treatments and high cost of targeted therapies in the palliative setting makes the search for new prognostic/predictive biomarkers an important clinical goal.


Eligibility criteria:
inclusion criteria: 1. ecog performance status 0-2 2. age over 18 years 3. diagnosed renal cancer with clear cell histology 4. metastatic disease 5. predicted life expectancy over 2 months 6. targeted treatment with an anti-vegf or anti-mtor agent as first or second line therapy 7. standard imaging evaluation 4 weeks prior to inclusion 8. planned for standard imaging within 16 weeks after start of therapy exclusion criteria: 1. presence of substantial comorbidities (uncontrolled heart or respiratory dysfunction, severe renal or hepatic impairment \[cl cr below 30ml/h or bb\>3x uln\]) 2. history of a malignancy other than non-melanoma skin cancer in the previous 5 years 3. any other contraindication to targeted treatments.
efficacy of three dimensional transesophageal echocardiography for percutaneous device closure in atrial septal defect

Conditions: Atrial Septal Defect; Successful Device Closure

Summary: background: three-dimensional echocardiographic image for atrial septal defect (asd) is useful for evaluation of defect size and shape. the investigators suggested optimal device size using three-dimensional transesophageal echocardiographic image and our formula in previous study. purpose: in this study, the investigators seek to predict the correct device size and confirm the accuracy of the formula that we made before device closure in asd patients.


Eligibility criteria:
inclusion criteria: * age ≥18 year-old * susceptible indication for atrial septal defect closure * potential candidate for device closure exclusion criteria: * poor candidate for device closure: multiple asds, ect * other heart disease requiring open heart surgery
neuropsychological and brain medical imaging study in patients with brain damage 2

Conditions: Cerebrovascular Disorders; Brain Lesion; Degenerative Disease; Developmental Disability

Summary: two groups of subjects will be constitute: (i) patients with circumscribed brain injury (including stroke, vascular malformations, tumor or circumscribed infectious lesions) or degenerative/developmental disorders and selective cognitive disorders; (ii) healthy control subjects. the objective of this project is to evaluate specific neuropsychological deficits and apply current brain imaging techniques (anatomical, diffusion, functional, magnetic stimulation) to patients suffering from these cognitive deficits due to brain damage, in order to elucidate the brain mechanisms underlying these deficits.


Eligibility criteria:
inclusion criteria: * age \> 17 years * french language * effective contraception for women during the study * informed consent * no alcohol intake the day before the exam * for patients only, focal cerebral lesion (stroke, malformation, tumor, inflammatory, infectious, traumatic), neonatal pathology, developmental or degenerative disease with cognitive deficit exclusion criteria: * for healthy volunteers: previous neurological history (except non complicated migraine or epilepsy), previous psychiatric history (except depression with good evolution or anxiety), or severe cranial traumatism * for patients: vigilance disorders, severe depression or anxiety. * for both: psychotropic medication other than a hypnotic or an anxiolytic at low doses without dose modification for at least one month, severe visual or auditory impairment, patient without judicial or administrative liberty, measure of legal protection or no capable to express their consent, pregnancy or breastfeeding, contraindication for mri or gvs if applicable, participation in another trial or former involvement in another trial within one month.

Keywords: neuropsychological study brain imaging
pharmacokinetics of a fixed dose combination of canagliflozin/metformin coadministered with food

Conditions: Healthy Volunteers

Summary: the purpose of this study is to assess the effect of coadministration of a high-fat meal on the oral bioavailability of a fixed dose combination of canagliflozin/extended release metformin (cana/met xr) tablet, containing 150 mg cana and 1,000 mg extended release met in healthy participants.

this is a randomized (a sequence of fasted and fed periods accompanying study drug intake will be assigned by chance), open-label (physicians and participants know the identity of the assigned treatment), single-center, single-dose, 2-period, 2-sequence, crossover study of canagliflozin/extended release metformin (cana/met xr) fixed dose combination (fdc) tablet of 150 mg/1,000 mg. approximately 24 healthy adult participants will be enrolled to ensure that at least 20 complete the study. after a screening period, participants will be randomly assigned to 1 of the 2 treatment sequences (ab or ba) on day 1 of period 1. treatment a means a participant will receive a single 150/1,000 mg cana/met xr fdc tablet under fasted conditions, and treatment b means that a participant will receive the same drug under fed conditions. participants will need to remain at the study center for 4 days (72 hours postdose) after the drug administration for collection of blood samples in each treatment period. there will be a 10- to 14-day washout period between period 1 and period 2. on day 4 (72 hours postdose) of period 2, when participants are discharged from the study center, they will be given instructions to return for a follow-up visit 7 to 10 days later. for treatment b (in fed state), participants will be provided with a standardized high-fat breakfast. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * must sign an informed consent document indicating they understand the purpose of the study and procedures * must have a body mass index (bmi) of between 18 and 30 kg/m², inclusive * must have a body weight of not less than 50 kg * must have a blood pressure between 90 and 140 mmhg inclusive, systolic, and no higher than 90 mmhg diastolic at screening * must have normal renal function and no evidence of kidney damage (including abnormalities in blood or urine tests) exclusion criteria: * history of or current clinically significant medical illness * use of any prescription or nonprescription medication (including vitamins and herbal supplements) * history of clinically significant allergies, especially known hypersensitivity or intolerance to lactose- known allergy to heparin or history of heparin induced thrombocytopenia * history of smoking or use of nicotine-containing substances within the previous 2 months

Keywords: healthy volunteers canagliflozin metformin invokana® type 2 diabetes mellitus
the hemostatic effectiveness of "hanbio" gauze during non-emergent gynecology surgery.

Conditions: Wounds and Injuries; Hemostasis

Summary: the objective of this study is to collect the hemostatic effectiveness and device safety data of "hanbio" gauze in subjects have acute wound result from gynecology surgery.


Eligibility criteria:
inclusion criteria: * female between 20 and 70 years of age. * subject scheduled for a non-emergent, gynecological surgery. * subject has an identified bleeding site/area intraoperatively. * subject is willing to comply with all aspects of the study and have signed informed consent form. exclusion criteria: * pregnant or lactating female. * the wound is chronic wound that not healed within 8 weeks, e.g. ulcers. * the wound is caused by radiation or burns. * subject is sensitive or allergic to collagen. * subject is sensitive or allergic to polyester (pet). * subject has medical history of coagulation disorder or disease (e.g., hemophilia, thrombocytopenia). * subject receives anticoagulants or antiplatelets. * subject plans to receive other hemostatic gauze/dressing/agent/medical device as primary hemostasis. * subject has participated in another clinical trial within the past 30 days. * subjects with any pre-operative or intra-operative findings that may preclude conduct of the study procedure or unable to evaluate the outcomes.
a randomized blinded trial of abscess management with packing vs no packing

Conditions: Uncomplicated Cutaneous Abscess

Summary: adult patients presenting to the emergency department with superficial cutaneous abscesses will be randomized after incision and drainage to standard care with wound packing or no packing to determine if there is a difference in the proportion of complications between the two groups.


Eligibility criteria:
inclusion criteria: * ≥ 18 years * abscess ≤ 5cm in diameter * truncal or extremity location exclusion criteria: * post-operative abscess (abscess in location of operative incision, operation within the last 4 months) * hiv/immunocompromised/transplant recipient/chronic oral steroid use * fever at triage (temp ≥38 degrees celsius) * abscess secondary to crohn's * multiple abscesses requiring drainage * prior participation in the study for the same abscess * incision and drainage performed with no packing required, or where abscess cavity is \<1 cm max diameter * bartholins/perigenital, perianal, or facial abscesses * complicated abscesses (fistula, suspicion of muscular extension, consultation/direct referral to general surgery) * inability to give consent

Keywords: abscess packing emergency medicine wound care incision and drainage
lifestyle change to prevent diabetes via african-american churches

Conditions: Diabetes; Weight Loss

Summary: fit body and soul is single-blinded, cluster- randomized trial of a faith-based adaptation of the glb program compared with a health education intervention.


Eligibility criteria:
inclusion criteria: * self-described african american * bmi ≥25kg/m2 * planning to remain within the community for 1 year * non-diabetic exclusion criteria: * fasting plasma glucose ≥ 126 mg/dl following at least an 8-hr fast or a1c≥7.0% * hiv/aids * active tuberculosis * cancer requiring treatment in past 5 years except for cancers that have been cured or in the opinion of the researchers has a good prognosis * stroke within the past 6 months * cirrhosis of the liver * currently pregnant or planning pregnancy within the study period * gastric weight-loss surgery * weight loss \> 10% in past three months for any reason other than childbirth * anti-diabetic medications * prescription weight- loss medications * anti-neoplastic agents * anti-psychotic agents that have gluco-corticoid effect * oral corticosteroid use \>6 weeks * unwilling or unable to give informed consent * unable to communicate with the church team or research group * participation in another research study that would interfere with fbas
effects of virtual reality rehabilitation in patients with total knee arthroplasty

Conditions: Total Knee Replacement; Virtual Reality Therapy; Osteoarthritis; Knee Arthroplasty; Rehabilitation

Summary: the aim of this study is to assess the efficacy of virtual rehabilitation through the virtual reality rehabilitation system (vrrs) versus traditional rehabilitation improving the functional outcomes after primary total knee arthroplasty (tka).

following ethics approval by the ospedale san raffaele, 84 adults aged between 45 and 80 years old will be recruited for the study, excluding people with unstable serious disease (e.g., heart or lung disease), previous orthopedics pathologies on the same side (e.g., hip arthroprosthesis), pregnancy and intake of psychotropic drugs. patients who consent to participate in this study will be randomized into two rehabilitation groups after tka: experimental (virtual rehabilitation) and control (traditional rehabilitation). in the experimental arm, subjects will undergo a virtual rehabilitation training during the post-surgical rehabilitation period, in addition to passive knee range of motion device (kinetec) and functional activity (stairs). in the control arm, subjects with similar demographic characteristics to those of the experimental arm, will undergo the usual physiotherapy rehabilitation, in addition to passive knee range of motion device (kinetec) and functional activity (stairs). both control and study interventions will be provided 60 minute daily session. general status of patients will be undertaken for the following outcomes at the baseline and 10 days after surgery (at discharge). the primary outcome will be the visual analogue scale (vas); the secondary outcomes will be: the disability knee assessed by the western ontario and mcmaster universities (womac), the health related quality of life assessed by the euroqol (eq-5d), the global perceived effect assessed by the gpe score, the functional independent measure assessed by the fim questionnaire, the drugs assumption, the isometric strength of quadriceps and hamstrings assessed by dynamometer, the range of motion (r.o.m.) and proprioception assessed by vrrs.

Eligibility criteria:
inclusion criteria: * primary unilateral tka for knee osteoarthritis * informed consent exclusion criteria: * people with unstable serious disease (e.g., heart or lung disease) * people with previous orthopedics pathologies on the same side (e.g., hip arthroprosthesis) * pregnancy * psychotropic drugs assumption

Keywords: virtual reality therapy rehabilitation total knee replacement knee arthroplasty exercise arthritis rheumatic disease
an efficacy and safety study to compare three doses of bea 2180 br to tiotropium and placebo in the respimat inhaler.

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the primary objective of this study is to compare the bronchodilator efficacy of three doses (50 µg, 100 µg and 200 µg) of bea 2180 delivered by the respimat® once daily to placebo and tiotropium bromide delivered by the respimat® in patients with copd. additional objectives include comparing the effects on dyspnea and health status.


Eligibility criteria:
inclusion criteria: 1. all patients must sign an informed consent consistent with ich-gcp guidelines prior to participation in the trial, which includes medication washout and restrictions. 2. all patients must have a diagnosis of chronic obstructive pulmonary disease (p95 4381) and must meet the following spirometric criteria: patients must have relatively stable, moderate to severe airway obstruction with an fev1 (post-bronchodilator, 30 minutes post salbutamol/albuterol) \<80% of predicted normal and fev1 less than or equal to 70% of fvc at the pfts at visit 1 (screening). 3. male or female patients 40 years of age or older. 4. patients must be current or ex-smokers with a smoking history of more than 10 pack years. patients who have never smoked cigarettes must be excluded. 5. patients must be able to perform technically acceptable pulmonary function tests and electronic pefr measurements, and must be able to maintain records (patient daily diary) during the study period as required in the protocol. 6. patients must be able to inhale medication in a competent manner from the respimat® inhaler (appendix i) exclusion criteria: 1. patients with significant diseases other than copd will be excluded. a significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient ability to participate in the study. 2. patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a significant disease as defined in exclusion criterion no. 1. 3. patients with a recent history (one year or less) of myocardial infarction. 4. patients with any unstable or life-threatening cardiac arrhythmia. 5. patients who have been hospitalized for heart failure within the past 3 years. 6. patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. patients with treated basal cell carcinoma are allowed. 7. patients with known symptomatic prostatic hyperplasia or bladder neck obstruction as defined in exclusion criteria no. 1. 8. patients with known narrow-angle glaucoma. 9. patients with asthma or a history of asthma. 10. patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis. 11. patients with known active tuberculosis. 12. patients with a history of and/or active significant alcohol or drug abuse. see exclusion criterion no. 1.